Description

Tolperisone Impurity B CAS NO 91625-74-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Tolperisone hydrochloride, a centrally acting muscle relaxant. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and routine quality control testing. The availability of a well-characterized impurity standard is essential for maintaining the integrity of the pharmaceutical supply chain.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tolperisone Impurity B in Tolperisone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to ensure API and drug products meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports impurity profiling, degradation pathway studies, and the synthesis of novel pharmaceutical compounds.

Basic Information

Product Name	Tolperisone Impurity B
CAS No.	91625-74-0
Molecular Formula	C16H23NO
Molecular Weight	245.36 g/mol
Synonyms	2-Methyl-1-(4-methylphenyl)-3-piperidin-1-ylpropan-1-one; 1-(4-Methylphenyl)-2-methyl-3-(1-piperidinyl)-1-propanone; Tolperisone Related Compound B; Tolperisone EP Impurity B; Tolperisone Hydrochloride Impurity B; α-Methyl-4-methyl-β-piperidinopropiophenone; Mephenoxalone Impurity (related structure)
EINECS	Contact for details

Quality Control

Every batch of Tolperisone Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.